País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND)
Avera McKennan Hospital
ORAL
PRESCRIPTION DRUG
TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because TIKOSYN can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES ). TIKOSYN is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. TIKOSYN has not been shown to be effective in patients with paroxysmal atrial fibrillation. TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes. TIKOSYN should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients wi
TIKOSYN 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with a light orange cap and white body, printed with TKN 125 PFIZER, and are available in: NDC 69189-5800-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store at controlled room temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP).
New Drug Application
Avera McKennan Hospital ---------- MEDICATION GUIDE TIKOSYN® (Tee' ko sin) (dofetilide) Capsules Read the Medication Guide before you start taking TIKOSYN and each time you get a refill. This information does not take the place of talking with your doctor about your condition or treatment. What is the most important information I should know about TIKOSYN? TIKOSYN can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. To establish the right dose of TIKOSYN, treatment with TIKOSYN must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of TIKOSYN that your doctor prescribed for you. While you take TIKOSYN, always watch for signs of abnormal heartbeat. Call your doctor and go to the hospital right away if you: • feel faint • become dizzy, or • have a fast heartbeat What is TIKOSYN? TIKOSYN is a prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter). It is not known if TIKOSYN is safe and effective in children under 18 years of age. Who should not take TIKOSYN? Do not take TIKOSYN if you: • have an irregular heartbeat called long QT syndrome • have kidney problems or are on kidney dialysis • take any of these medicines: • cimetidine (TAGAMET, TAGAMET HB)1 • verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN, VERELAN PM, TARKA)1 • ketoconazole (NIZORAL, XOLEGEL, EXTINA)1 • trimethoprim alone (PROLOPRIM, TRIMPEX)1 or the combination of trimethoprim and sulfamethoxazole (BACTRIM, SEPTRA SULFATRIM)1 • prochlorperazine (COMPAZINE, COMPO)1 • megestrol (MEGACE)1 • dolutegravir (TIVICAY)1 • hydrochlorothiazide alone or in combination with other medicines (such as ESIDRIX, EZIDE, HYDRODIURIL, HYDRO-PAR, MICROZIDE, or ORETIC)1 Ask your doctor if you are not sure if any of your medicines are the kind listed above. • are allergic to do Leer el documento completo
TIKOSYN- DOFETILIDE CAPSULE AVERA MCKENNAN HOSPITAL ---------- TIKOSYN (DOFETILIDE) CAPS ULES To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION. DESCRIPTION TIKOSYN (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C H N O S and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is: _N_-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. TIKOSYN capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. TIKOSYN is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules. CLINICAL PHARMACOLOGY MECHANISM OF ACTION TIKOSYN (dofetilide) shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I . At concentrations covering several orders of magnitude, dofetilide blocks only I with no relevant block of the other repolarizing potassium currents (e.g., I , I ). At clinically relevant concentrations, dofetilide has no effect on sodium channels (associated with Class I effect), adrenergic alpha-receptors, or adrenergic beta-receptors. ELECTROPHYS IOLOGY TIKOSYN (dofetilide) increases the monophasic action potential durati Leer el documento completo